Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia



Status:Terminated
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:July 20, 2017
End Date:February 5, 2019

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Interventional, Randomized, Double-blind, Active-controlled Study of the Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia

This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in
patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia
(TRS)

In the study, patients will receive risperidone (4-6 mg/day), or, if recently failed on
risperidone, olanzapine (15-20mg/day). Later during the study, patients will be randomized to
either receive Lu AF35700 (10 mg/day), or continue their treatment with risperidone or
olanzapine.

Inclusion Criteria:

- The patient has schizophrenia, diagnosed according to DSM-5(TM). (Diagnostic and
Statistical Manual of Mental Disorders) and confirmed by the Mini International
Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI-Schz).

- The patient is receiving treatment with a psychiatrist in either an inpatient or
outpatient facility.

- The patient has been treated with adequate dose(s) of antipsychotic drug treatment for
at least 2 weeks prior to the Screening Visit.

- The patient has failed to show an adequate response in the level of psychotic symptoms
during at least one documented treatment trial with an adequate dose of an
antipsychotic drug prescribed for an adequate time (at least lasting for 6 weeks)
within 2 years prior to the Screening Visit. The failure to respond to the current
antipsychotic drug treatment trial may be considered a retrospective failed treatment,
if the patient has been treated for 6 weeks with adequate dose(s) of antipsychotic
drug(s).

- The patient has a PANSS total score of ≥80 (on 1-7 scale) and a score of ≥4 (≥
"Moderate" on 1-7 scale) on at least 2 of the following PANSS items at the Screening
and at Baseline 1 [Week 0] Visits: P2 - Conceptual disorganization, P3 - Hallucinatory
behavior, P6 - Suspiciousness/persecution, G9 - Unusual thought content; AND the
patient has a CGI-S score of ≥4 (≥ "Moderately ill") at the Screening and at Baseline
1 (Week 0) Visits.

Exclusion Criteria:

- The patient has any current primary psychiatric disorder other than schizophrenia, as
assessed using the MINI-Schz.

- The patient suffers from mental retardation, organic mental disorders, or mental
disorders due to a general medical condition (DSM-5™ criteria).

- The patient is experiencing an acute exacerbation of his/her psychotic symptoms.

- The patient has been treated with, AND is resistant to, clozapine according to the
investigator's judgement.
We found this trial at
11
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Ann Arbor, Michigan 48105
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Fall River, Massachusetts 02720
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Fall River, MA
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2030 Portage Street
Kalamazoo, Michigan 49001
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Kalamazoo, MI
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Kardzhali,
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Kardzhali,
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2500 California Plaza
Omaha, Nebraska 68102
(402) 280-2700
Creighton University Creighton University, located in Omaha, Neb., offers a top-ranked education in the Jesuit...
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Omaha, NE
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
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Saint Louis, MO
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Salt Lake City, Utah 84105
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Salt Lake City, UT
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San Diego, CA
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Worcester, Massachusetts 01655
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Worcester, MA
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